FDA Device recall Z-0293-2018
Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Cert…
- FDA Device
- Class I
- terminated
- Published 2018-01-17
On 2018-01-17 the FDA classified a Class I recall of Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Cert… by Edwards Lifesciences, citing A component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the loader into th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0293-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-07-21 |
| Published | 2018-01-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Edwards Lifesciences |
| Distribution | US |
Product
Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Certitude Delivery System is used for delivery of the Edwards SAPIEN 3 transcatheter heart valve (THV), typically during a transapical (TA) or transaortic (TAo) approach to transcatheter aortic valve replacement.
Reason
A component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the loader into the patient.
Identifiers
| code_info | Lot Numbers: 60677653 60703356 60703356 60733369 60898859 60708907 60708907 60693311 60677343 60678033 6070…Lot Numbers: 60677653 60703356 60703356 60733369 60898859 60708907 60708907 60693311 60677343 60678033 60708907 60699067 60685057 60712982 60760615 60792834 60776987 60813952 60782083 60796436 60840392 60842807 60854965 60885861 60930443 60677270 60678035 60678040 60703355 60704423 60703355 60704423 60679106 60689105 60718006 60718007 60792838 60813951 60782088 60816613 60816614 60842808 60842810 60873492 60842809 60885862 60885863 60930444 60697333 60703357 60703357 60678007 60739663 60733367 60733366 60760822 60801453 60808313 60776988 60816615 60883652 60842811 60739661 60718977 60718978 60718979 60724851 60724852 60724853 60724854 60724855 60724856 60724857 60724858 60724859 60724860 60724861 60724862 60724863 60724864 60724865 60724866 60724867 60724868 60724869 60724870 60730280 60730282 60730283 60730284 60730285 60730286 60730287 60730288 60730318 60730289 60730319 60730320 60730 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0293-2018%22
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